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INDUSTRY INFORMATION SESSION 2012
Agenda
• Food Safety Enhancement Program (FSEP) update
• Validation of control measures
• HACCP system maintenance & reassessment
• Action plan
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• CFIA verification of FSEP recognized establishments (commodities other than meat)
• Compliance Verification System (CVS) update for meat establishments
• 5 most common CVS tasks rated U
• Questions & Answers
FSEP Update
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Food Safety Enhancement Program (FSEP)
• Prerequisite programs (PP)
• HACCP plan(s)
FSEP specifies the requirements for an effectiveHACCP system which includes
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• HACCP plan(s)
• Validation documentation
• HACCP system maintenance and reassessment procedures
Prerequisite programs
A. Premises
Basic conditions and activities that are necessary to maintain a hygienic environment and good manufacturing practices throughout the establishment.
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B. Transportation, Purchasing/Receiving/Shipping and Storage
C. Equipment
D. Personnel
E. Sanitation and Pest Control
F. Recall
Operational Prerequisite Programs
Food Safety related procedures essential in order to control the likelihood of introducing food safety hazards to and/or the contamination or proliferation of food safety hazards in the product(s) or in the processing environment.
New
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G. Operational Prerequisite Programs• G.1.1 Allergen Control Program
• G.1.2 Food Additives and Nutrients
• G.1.3 Food Processing Aids
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G.1.2 Food Additives and Nutrients
1. The use of food additives listed in the tables in Part B, Division 16 of the Food and Drug Regulations for which a maximum level of use is identified.
This sub-element applies to three operational activities requiring control measures.
New
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2. The use of nutrients listed in Part D – Vitamins, Minerals and Amino Acids of the Food and Drug Regulations for which a minimal and maximal amount is specified in Part B of the Regulations.
3. The use of modified atmosphere packaging systems.
G.1.3 Food Processing Aids
This sub-element applies to food processing aids for which maximum levels of use have been established by Health Canada.
A food processing aid is a substance that is used for a technical
New
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A food processing aid is a substance that is used for a technical effect in food processing or manufacture, the use of which does not affect the intrinsic characteristics of the food and results in no or negligible residues of the substance or its by-products in or on the finished food.
Task versus Monitoring
TaskOperational activities that are part of a prerequisite program and that are carried out by designated employees to prevent a food safety hazard.
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MonitoringThe act, by company personnel of conducting a planned sequence of observations, tests or measurements to assess whether a CCP, a process control and/or a prerequisite program is under control.
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Example of Task vs Monitoring
• A list of equipment that may impact on food safety requiring regular
maintenance;
C.1.2.1 Preventative Equipment Maintenance Program
The establishment has and implements a documented Preventative Equipment Maintenance Program which includes but is not limited to:
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• A preventative maintenance schedule or frequency of preventative
maintenance activities;
• The maintenance procedures to perform for each preventative
maintenance task;
• Records to be kept to demonstrate that the preventative
maintenance tasks have been completed.
The equipment maintenance program includes tasks to be performed by the maintenance employees. The program will be monitored at a frequency X to ensure that it is effectively implemented.
Task vs Monitoring – continued
• A.4.1.1 – Water safety procedures
• A.4.1.2 – Water treatment procedures
All these programs include tasks to be performed by designated employees. Monitoring activities will be conducted at a determined frequency to assess if the procedures in place are effective to prevent a hazard to occur.
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• C.1.2.1 – Preventative equipment maintenance program
• C.1.2.2 – Equipment calibration program
• D.1.1.1 – General food hygiene training program
• D.1.2.1 – Technical training program
• E.1.1.1 – Sanitation program
• E.2.1.1 – Pest control program
• Etc.
Task vs Monitoring – continued
An establishment may want to develop more procedures or tasks to facilitate the control of a prerequisite program requirement.
Any additionnal procedures or tasks must be
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Any additionnal procedures or tasks must be referenced within the respective prerequisite program bullet.
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FSEP – List of Modifications
Go to tab 3 – FSEP Manual list of modifications
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New HACCP plan or New process to an existing HACCP plan
Inform CFIA Inspector prior to the commencement of the new process
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High risk category Lower risk category
Written review by CFIA prior to the
commencementof new process for commerce
Written review by CFIA can occur after
the commencement of new process for commerce
High Risk Category
• The process involves a kill step to eliminate microbial contaminants, or a step to reduce them to an acceptable level. For example, pasteurization, sterilization, cooking, drying, fermentation.
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• Hazards are inherent to the process and the product is considered ready to eat, without further processing by the consumer.
• The production involves a complex recipe. It may involve the use of chemical hazards (e.g. nitrates) or involve a product that addresses serious nutritional concerns.
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Lower Risk Category
• Hazards are inherent to the process but the processing controls are not designed to eliminate these hazards. Rather, the controls (such as proper sanitation and temperature control) are meant to prevent contamination or to prevent an increase to existing biological hazards. Product will be further
d b th / li t h d t f ll
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processed by the consumer/client, who may need to follow specific handling and storage instructions.
• Products are ready to eat but do not pose significant health hazards on their own. For example, thermal processing or aseptic processing for high-acid food, maple product processing, honey processing, freezing, packaging, drying of fruits.
New HACCP Tools Available
• Prerequisite Programs Generic Model
• Senior Management Letter of Commitment
• HACCP System Performance Reporting
• HACCP System Maintenance and Reassessment Procedures
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Procedures
• Validation Checklist
Validation
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What is Validation?
Obtaining evidence that a control measure is capable of controlling a specific hazard to a specified outcome
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Under the FSEP Manual, which control measures must be validated?
Control measures related to;
• Critical control points
• Process controls
• Prerequisite programs that can lead to a food
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• Prerequisite programs that can lead to a food safety incident if not capable of controlling the specified standards
When to Validate?
• At the time a control measure is designed and, whenever possible, before full implementation
• System failure
• Changes made to a control measure
New scientific or regulatory information
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• New scientific or regulatory information
• Emergence of a previously unidentified hazard (e.g. new pathogen)
• New information indicating that the hazard is not being controlled to the level specified (e.g. new internationally accepted analytical technologies)
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What is CFIA looking for?
Documentation to demonstrate that:
• the control measure works in theory
• the control measure works in practice
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What type of documentation does CFIA expect for Validation?
Go to tab 4 – Validation checklist
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HACCP System Maintenance & Reassessment
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HACCP System Maintenance
Continuous changes to a HACCP system to keep it up-to-date and a true reflection of the establishment’s controls
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What kind of changes?
For example:
• New product
New ingredients
Any changes that affect the HACCP system design and implementation
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• New ingredients
• New monitoring frequency
• New equipment
• New sanitation procedures
• New production areas
• New regulatory requirements
HACCP System Maintenance Procedures
• The name or title of personnel responsible to make changes to the
HACCP system
• The name or title of personnel responsible to ensure that the
changes are implemented effectively
• A method to identify the revised versions
• The use of a log book or equivalent which must at least contain the
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• The use of a log book or equivalent which must at least contain the
following information:
• A description of the changes
• The signature or initials of responsible person who made the change
• Where the changes occurred in the HACCP system
• The dates when changes are implemented, reassessed and, if necessary, validated
• The signature or initials of responsible person who ensure the changes are
implemented effectively
• The revision date or number that correlates with document changed
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Example of a Maintenance Procedure
Go to tab 5 – Example of a Maintenance Procedure
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HACCP System Reassessment
Assessment to ensure that the HACCP system currently in place is complete and effective
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When to Reassess?
• Whenever any changes or situations occur that could affect the hazard analysis or alter the HACCP system
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• At least annually
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Annual HACCP System ReassessmentTwo (2) objectives
To ensure that the HACCP system is COMPLETE
• Up-to-date
• Identifies all food safety hazards
• Has control measures in place for all food safety hazards which may be controlled by the establishment
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which may be controlled by the establishment
• Conforms to current regulatory and CFIA program requirements
• Conforms to the requirements defined in the FSEP manual
To ensure that the HACCP system is EFFECTIVE
• Results in the desired outcomes
Example of Reassessment Procedures
Go to tab 5 – Example of Reassessment Procedures
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Action Plan
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Why is CFIA asking for Action Plans?
• To address non-compliance to regulatory requirements identified through inspection activities
• To have written corrective measures endorsed by
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To have written corrective measures endorsed by representatives of Senior Management
Action plans form part of a continuous compliance process
What is the positive aspect for establishments?
A clear and comprehensive action plan allows for
• better understanding of the non-compliance causes
• better understanding of each person’s roles and responsibilities
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p
• better use of resources
• better coordination of staff involved in corrective actions
• better resolution of problems
What is CFIA looking for?
Problem description
Person(s) responsible for measures
Description of immediate short term measure
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Identification of root cause(s)
Description of preventative measure(s)
Description of activities planned to verify effectiveness of preventative measure(s)
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EXAMPLE OF AN ACTION PLAN
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On August 15, 2011 at approximately 22:15, the inspector noted 2 skids of raw
product were being tempered in Chill Room A; the room temperature was 22 oC.
The inspector spoke with QA Supervisor, who indicated the room temperature was
19 oC at 17:00 monitoring time which was within plant specification (QASOP #123
indicates room must not exceed 21 oC during tempering).
The inspector spoke with Production Supervisor, who indicated that the product was
‘rock solid’ so the doors will be closed going into Chill Room A and the fan will be
Situation that resulted in the CAR:
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turned on to ensure that the raw product would be ready to be used during the
morning of Aug. 16.
Inspector noted that the product was completely thawed and requested that QA take
a product temp.
The internal temperatures were between 5 and 6 oC at 22:30 on Aug. 15.
Operator’s written program did not require documented temperature monitoring of
tempered product. As such, no records were available to demonstrate that product
tempered within the facility was stored in a manner to prevent temperature abuse.
WHY DID CFIA HAVE TO IDENTIFY THE NON-COMPLIANCE IN THE FIRST PLACE?
IMPORTANT QUESTIONS TO ASK YOURSELF WHEN YOU RECEIVE A CAR
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WHICH PART OF OUR SYSTEM FAILED TO IDENTIFY IT AND RESPOND TO IT APPROPRIATELY BEFORECFIA ISSUED THE CAR?
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Scope:1a) What is the non-compliance?
1b) When did the problem occur? Is this the first time the problem has occurred?
1c) Where is the problem located? Does the deficiency ff t th f th f ilit HACCP t ? H
Problem Description – Component 1
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affect other areas of the facility or HACCP system? How widespread is the problem?
1d) Who is involved in this problem?
1e) Did the problem affect product?
1a) What is the non-compliance?
• The room temperature, where the raw product was being thawed, was
above the company’s written standard of 21oC.
• The raw product internal temperature was above 4oC.
• The raw material temperature of product tempered in Chill room A was not
documented.
1b) When did the problem occur? Is this the first time the problem has
Problem Description – Component 1a, b
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1b) When did the problem occur? Is this the first time the problem has
occurred?
• The events took place on August 15, 2011 at 22:15.
• Chill room A temperature is documented once every shift. No deviations
from the written standards were noted for the last three months.
• The plant has never documented raw material temperatures.
1c) Where is the problem located? Does the deficiency affect other areas of
the facility or HACCP system? How widespread is the problem?
• Only Chill room A is used for tempering/thawing. QA SOP #777-Chill
Room A Temperature Control must be reviewed.
• QA SOP #789 for “Tempering of Frozen Product” does not address the
Problem description – Component 1c
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tempering of raw material using proper controls.
Note: Tempered raw material is checked regularly by QA and/or
Production staff even though this is not documented.
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1d) Who is involved in this problem?• QA Supervisors, QA Manager, Production Supervisors,
Production Manager
1e) Did the problem affect product? • YES, the raw material was affected by the problem. No finished
Problem Description – Component 1d & e
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y pproduct was impacted, since the raw material was immediately put on hold.
Scope: Identify the title of person(s) responsible for the immediate/short term and preventative measures. (must have the knowledge, time, competence, authority to implement).
Position of responsible person(s)
Person(s) Responsible for Measures –Component 2
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-Position of responsible person(s)
-Name of responsible person(s)
Scope: Identify the title of person(s) responsible for the immediate/short term and preventative measures.
- Position of responsible person(s)QA Supervisor
P d ti S i
Person(s) Responsible for Measures –Component 2
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Production Supervisor
Food Safety HACCP Coordinator
- Name of responsible person(s)Bob Hall
Manny White
Joe Smith
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Scope:
3a) Describe the measures taken on affected or potentially affected product, animals or other thing(s). (e.g.: put product on hold, immediately do missed check, etc.)
Description of Immediate Short Term Measure(s)
– Component 3 a, b, c
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3b) Describe the results of the assessment completed to determine if other products, animals or other things were implicated.
3c) Describe the Food Safety Assessment (FSA) performed or to be performed on the affected or potentially affected product including any disposition of product. Attach separate FSA form if applicable.
3a) Describe the measures taken on affected or potentially affected product, animals or other thing(s).
2 skids [lot number X] were immediately isolated placed
Description of Immediate Short Term Measure(s)
– Component 3
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2 skids [lot number X] were immediately isolated, placed on hold (Hold Tag #100) and at 23:00 moved into Chill Room C at 1oC to lower temperature.
3b) Describe the results of the assessment completed to determine if other products, animals or other things were implicated.
Only 2 skids in Chill Room A at that time
Description of Immediate Short Term Measure(s)
– Component 3
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Only 2 skids in Chill Room A at that time.
All raw material that is being thawed in Chill Room A is only used on Lines X & Z. All finished products produced on Lines X and Z undergo microbiological testing for TPC, Coliform and generic E-coli. All results have been found acceptable.
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3c) Describe the Food Safety Assessment (FSA) performed or to be performed on the affected or potentially affected product including any disposition of product. Attach separate FSA form if applicable.
The affected raw material was moved into Chill Room C at 23:00
Description of Immediate Short Term Measure(s)
– Component 3 continued
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The affected raw material was moved into Chill Room C at 23:00.
Chill Room C is maintained at 1oC. The raw material temperature was at 4oC after 2 hours (1:00 am) Chill Room C Product Temperature Record.
The affected raw material was used on Lines X & Z on August 16. Finished product was held for microbiological testing for TPC, Coliform and generic E-coli. All results have been acceptable. The finished product was released on August 19.
3d) Describe the immediate/short term measures taken to restore control over the deviation until permanent/preventative measures are planned and implemented, include position titles (from Component 2)
Description of Immediate Short Term Measure(s)
– Component 3d
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implemented, include position titles (from Component 2) and the date for completion of each activity planned.
Immediate Short Term Measure(s)– Component 3d
Immediate / Short term measures Position titles
Completion Date
1. The internal temperature of the raw material was immediately taken and found to be between 5 and 6oC.Recorded on new form: Chill Room A -T t R d
QA Supervisor
August 15, 2011
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Temperature Record.
2. The raw material was immediately isolated, placed on hold (Hold Tag #100) and at 23:00 moved into Chill Room C.
QA Supervisor
August 15, 2011
3. The raw material was used in the production on August 16, 2011. Finished product [lot #] was held and tested.E-mail sent to Plant Manager, QA Manager, QA Supervisor and Production Supervisors.
Production Manager
August 19, 2011
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Immediate Short Term Measure(s)– Component 3d
Immediate / Short term measures Position titles
Completion Date
4. Surface and/or internal temperatures of raw material being thawed between August 16 and August 25 (implementation date of the revised QASOP #789 - Tempering of Frozen P d t) ill b it d 2 h d
QA Supervisor
August 25, 2011
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Product) will be monitored every 2 hrs. and recorded on new form: Chill Room A -Temperature Record.
3e) Describe the procedures to verify effectiveness of immediate/short term measures taken, include position titles (from Component 2) and the date for completion of each activity planned.
Description of Verification of Effectiveness of Immediate/Short Term Measures
– Component 3e
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of each activity planned.
Verification of Effectiveness of Immediate/Short Term Measures
– Component 3e
Procedures to verify effectiveness of immediate / short term measures
Position titles
Completion Date
1. The internal temperature of the raw material was monitored in Chill Room C every 2 hrs.
d d d Chill R C T t
Production Supervisor
August 16, 2011
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and recorded on Chill Room C - Temperature Record.Chill Room C is maintained at 1oC.The raw material temperature was found to remain between 3 and 4oC.
2. & 3.Daily reconciliation of the held raw material was completed as per plant Hold & Release procedures QASOP #345 and recorded on the Hold Template.
Production Supervisor
August 16, 2011
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Verification of Effectiveness of Immediate/Short Term Measures
– Component 3eProcedures to verify effectiveness of immediate / short term measures
Position titles
Completion Date
3. Daily reconciliation of the held finished product was completed as per plant Hold & Release procedures QASOP #345 and recorded on the Hold Template issued
Production Supervisor
August 19, 2011
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recorded on the Hold Template issued.
3. Finished product [lot #] was tested for TPC, Coliforms and generic E-coli. All results have been acceptable as recorded on the Lab Report. The finished product was released on August 19 as per the Release Template.
QA Supervisor
August 19, 2011
Verification of Effectiveness of Immediate/Short Term Measures
– Component 3e
Procedures to verify effectiveness of immediate / short term measures
Position titles
Completion Date
4.New form: Chill Room A - Temperature records are reviewed for accuracy daily (by i i d d ti th d) t
QA Supervisor
August 25, 2011
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signing and dating the record) to ensure surface and internal temperatures of raw material being thawed meet the standards.
Scope:
This step is critical to fixing the non-compliance so that it does not re-occur.
Determine the root cause(s) of each non-compliance.
Identification of Root Cause(s)– Component 4
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Determine the root cause(s) of each non compliance.
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Non-Compliance (from Component 1a):
• The room temperature, where the raw product was thawed, was above
the company’s written standard of 21oC.
• The raw product internal temperature was above 4oC.
• The raw material temperature of product tempered in Chill room A was
not documented.
Questions
Identification of Root Cause(s)– Component 4
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Is there a control in place?
If yes, would the current monitoring program have identified the issue?
Why has CFIA found the problem and not the plant?
Is there anything else? (e.g. Training, ventilation/cooling system)
Root Cause:- The room temp. monitoring frequency of once per shift is not
effective in controlling the Chill Room temperature standards.- There was no record created to document the raw product temp.
results.
Description of preventative measure(s) and activities planned to verify effectiveness of
preventative measure(s) – Components 5 & 6
Component 5
Scope: Describe the preventative measures include position titles and the date for completion of each activity planned.
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Component 6
Scope: Describe the procedure(s) to verify the effectiveness of the preventative measures include position titles and the date for completion of each activity planned.
Description of Preventative Measure(s) –Component 5
Preventative measures Position Titles
Completion Date
• Revise QASOP #777 – Chill Room A C
Root Cause (from Component 4):- The room temp. monitoring frequency of once per shift is not effective in
controlling the Chill Room temperature standards.- There was no record created to document the raw product temp. results.
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Temperature Control to increase the monitoring frequency when product is thawed.• Modify the new form, QA #777-1.
Food Safety HACCP Coordinator
August 22, 2011
• Train the applicable employees on both the SOP & the modified form. • Record the training on the Training Record.
• Maintenance staff to set up an alarm when Chill Room A temperature reaches 20oC during thawing process.
Maintenance Supervisor
August 25, 2011
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Description of activities planned to verify effectiveness of preventative measure(s) –
Component 6
Procedures to verify effectiveness of preventative measures
Position Titles
Completion Date
A training effectiveness check will be conducted on each trained individual by a quiz and / or an on-site assessment while the individual is following the SOP & form and will include a
Production Supervisor
August 30, 2011
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following the SOP & form, and will include a document review.The findings will be documented on the original Training Record. Any non-compliance will be addressed by issuing a Deviation Report.
A test of the Chill Room temperature alarm is conducted to ensure that the alarm is triggered at >20 oC. The results are documented on a work order report.
Maintenance Supervisor
August 30, 2011
Verification of HACCP system in CFIA recognized establishments
(other than registered meat establishments)
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Purpose of the Verification by CFIA
To confirm that the establishment’s HACCP system
• is up-to-date
• is designed to effectively control food safety hazards
meets the FSEP requirements
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• meets the FSEP requirements
• is effectively implemented as described
• is supported by the establishment senior management
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Frequency of CFIA Verification
Once every 2 years and whenever the following situations occur.
• submission of new HACCP plans
follow up after a food safety recall
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• follow-up after a food safety recall
• when establishments fail to correct food safety related non-compliance noted during regular CFIA inspection activities
Duration of Verification
The time period established for completing a verification is approximately 5 days.
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FSEP Verification Tasks
There are 2 verification tasks
Task #1 is used only when new HACCP plans are submitted.
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Task #2 is used when:
1. scheduled CFIA verifications are conducted
2. follow-up after a recall is conducted
3. establishments fail to correct food safety related non-compliance noted during regular CFIA inspection activities
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Task #1 – New HACCP Plan
• Instructions on how to assess HACCP plan design
• Product description
• Product ingredients and incoming materials
• Process flow diagram
• Plant schematic
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• Hazard analysis - CCP determination and other control measures
• Critical Control Points
• Process Control if applicable
• Instructions on how to assess implementation
• Critical Control Points and Process Controls, if applicable
Task #2
Instructions on how to assess HACCP system design and implementation
The scope must at least include:
Th i t l tt f it t
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• The senior management letter of commitment
• The HACCP system performance reporting
• The maintenance and reassessment procedures
• One (1) selected HACCP plan
• Six (6) selected prerequisite program sub-elements
Task #2 – Selection of HACCP Plan and Prerequisite Programs
Based on CFIA compliance documentation and
situations that have occurred at the
t bli h t th t h ld h lt d i
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establishment that should have resulted in an
update and/or reassessment of parts of the
HACCP system
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Task #2 – Selection of HACCP Plan and Prerequisite Programs
CFIA Compliance Data
• Inspection reports and related actions plans
• Consumer complaints investigated by the CFIA
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• CFIA sample results and related action plans
• Detention and other enforcement issues or actions
Task #2 – Selection of HACCP Plan and Prerequisite Programs
List of triggers for HACCP system reassessement• New ingredients that contain an allergen
• Unsatisfactory laboratory results
• Consumer/client complaint
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• Food safety recall
• New technology or piece of equipment
• Change made in product description (shelf life, labelling instructions, etc.)
• Change made in production volume
• Non-compliance identified during CFIA inspection
• Etc.
Task #2 – Selection of HACCP Plan
HACCP Plan(s) affected by changes or compliance issues• CFIA will select the corresponding HACCP plan
CCP and/or PC affected by changes or compliance issues in other HACCP plan(s) than the one selected
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issues in other HACCP plan(s) than the one selected• CFIA will add the CCP and/or PC to the scope
No HACCP plan affected by changes or compliance issues• CFIA will randomly select one HACCP plan (higher
risk to human health)
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Task #2 – Selection of Prerequisite Programs
CFIA will select sub-elements(s) affected by changes or compliance issues
If there are less than 6 sub-elements affected by h li i CFIA ill l t
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changes or compliance issues, CFIA will select additional sub-elements to reach a total of 6
Compliance Level
Based on the information gathered, the CFIA team assigns a level of compliance to the task they complete:
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“A” Acceptable level of compliance
“U” Unacceptable level of compliance
Acceptable Level of Compliance (A)
The level of compliance is acceptable when the information collected demonstrates that the HACCP system:
• meets the FSEP requirements
• is designed to effectively control food safety hazards
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• is effectively implemented as described
• is supported by Senior Management
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Acceptable Level of Compliance (A)
• The CFIA team may identify minor items that have
no impact on food safety and/or do not
compromise the intent of the FSEP requirements
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• Documentation of these items is required
if there is an added value
Unacceptable Level of Compliance (U)
The level of compliance is unacceptable when the information collected demonstrates that the HACCP system:
• does not meet the FSEP requirements
• is not designed to effectively control food safety hazards
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• is not effectively implemented as described
• is not supported by Senior Management
Results of the verification is communicated to the operator through 2 documents
The FSEP Verification Report (Task rated A)
The Corrective Action Request (Task rated U)
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q ( )
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Corrective Action Request (CAR)
The CAR identifies the non-compliance and requires the operator to implement corrective measures by:
• Providing an acceptable action plan by a specified date
• Effectively implementing the corrective and preventative measures as described in the action plan by a specified date
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The CAR also describes the information gathered during the follow-up verification conducted by CFIA after the date for completion of corrective measures specified on the CAR
Request for Review of a CAR
An Operator may request a review of a CAR before the date specified for the submission of an action plan
The Operator must submit the reason for the request in writing to the Area FSEP Coordinator
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A written decision is forwarded back to the Operator
Action Plan Extension
Is provided when:
• Food safety is not compromised
• The establishment will not meet the specified date for completion of corrective actions due to reasons beyond its control
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beyond its control
• The establishment submits a written request for an extension before the specified date for completion of the action plan
• The written request includes the reason for the extension request and the proposed new completion date
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CFIA Follow-up on CAR
CAR closed CAR remains openCAR remains open
Maintain FSEP/HAACPrecognition
Final Notice of NonFinal Notice of Non--ComplianceCompliance
Satisfactory Unsatisfactory
CFIA Follow-up
CAR closed Loss of recognitionLoss of recognition
Maintain FSEP/HACCPrecognition
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Satisfactory Unsatisfactory
Compliance Verification System (CVS) Update
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ROLES AND RESPONSIBILITIES
As a licensed operator of a registered establishment you must:
Ensure your company and/or your product complies with the laws of Canada
Take effective action when issues of non-compliance occur
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CFIA must:
Assess your compliance to the Meat Inspection Act and Regulations and other applicable legislation
Take enforcement action when there are reasonable grounds to do so
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What is CVS?
CVS is a tool that provides a consistent approach to
1. Conducting inspection activities • Meat Hygiene Manual of Procedures Chapter 18, Verification tasks
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2. Documenting inspection activities • Verification report, Corrective Action Request
3. Reporting on inspection activities• CVS Performance Data Reports
CVS Performance Data Reports
• Generated each quarter
• Distributed to National, Area and Regional Management
• Used to identify:
T d
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• Trends• Resource issues• History of compliance• High risk inspection activities• Program delivery issues• CVS documentation issues
CVS Maintenance
Changes or situations may include:
Whenever a change or a situation occurs that could affect the CVS Tasks or Chapter 18, the CFIA reviews and updates the affected Tasks or Chapter 18 sections.
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• New or amended regulatory requirements
• Risk based strategy results
• New CFIA actions to be implemented
• CFIA inspectors or Industry concerns related to the tasks or Chapter 18 guidance
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New or Amended Requirements
Revision of the Meat Inspection Regulations
1. To repeal certain obsolete and redundant requirements
2. To streamline provision/requirements
3. To convert prescriptive requirements, namely requirements that specify how an outcome must be achieved, where possible, to outcome based requirements
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outcome based requirements
4. To ensure consistency in terminology with other CFIA administrated Regulations
5. To amend incorrect terminology
6. To increase alignment with regulations and policies of Canada’s major trading partners including the United States and the European Union
List of amendments can be found in Canada Gazette Part II, Vol 145, No23
CVS Update vs New or Amended Requirements
Example of Tasks affected by regulatory or policy changes:
• 1.2.01 (Outside property)
1 2 36 (Building Design and Construction)
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• 1.2.36 (Building Design and Construction)
• 1.2.38 (Allergen Control Program)
Risk Based Strategy
1. Historical – Industry non-compliance data
2. Listeria control results
The Risk Based Strategy determines CVS task frequency using 6 risk elements:
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3. HACCP system design task results
4. Forecasting activities
5. Foreign audit findings
6. Overall impact of each task on food activity
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CVS Update vs Risk Based Strategy Results
The verification frequency was lowered due to improved industry compliance for the following verification tasks:
• 1.1.11 (Formulation)
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1.1.11 (Formulation)
• 1.1.12 (Foreign metal detection)
• 1.2.11 (Poultry slaughter – Application of water spray)
• 1.2.15 (Poultry slaughter – Ante mortem screening)
CFIA action to be integrated into CVS
Repetitive, recurrent or systemic Repetitive, recurrent or systemic Listeria problemListeria problem
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Intensified CFIA InspectionIntensified CFIA Inspection
CFIA InCFIA In--depth reviewdepth review
Problem not resolved
CVS Update vs In-Depth Review
Task 4.2.01• Goal: FIND THE ROOT CAUSE
• Task instructions focus on on-site verification and HACCP system assessment
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Chapter 18, subsection 18.7.1.3• Who should be part of the CFIA team
• Steps prior the in-depth review
• How to report results to operator
• Task 4.2.01 is rated U
• All relevant information will be noted on an Inspection Report-Corrective
Action request
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CVS Update vs Industry Concerns
Concern #1
• Inspectors identified deficiencies on open CAR that were not related to the non-compliance identified in the open CAR
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CVS Update
• Chapter 18.7.2.3 – Identifying non-compliance that is related to an open CAR
Is the N/C observed directly related to the non-compliance described in the open CAR?
Is the operator in control of the situation? Document in separate CARDocument in separate CAR
Yes No
Yes No
May note the info in open CAR
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Document in open CAR
CVS Update vs Industry Concerns
Concern #2
• Difficult to close a CAR. During follow-up activities, inspectors identified deficiencies that were not related to the non-compliance identified in the CAR.
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CVS update
• Chapter 18.7.6.2 – Follow-up on non-compliance identified on the CAR
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Current Situation
• Information on federally registered meat and poultry establishments is frequently needed by the CFIA for:resource exercises i k t i
New Updated CVS Establishment Profile
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risk management exercisesrisk based sampling purposesmedia requests foreign country requests (i.e. FSIS’s SRT)etc...
• The same information is often requested several times a year by different groups and for different projects.
Solution
• The "CVS Establishment Profile" will be modified to become one extensive questionnaire/survey sent to inspection staff for each federally registered meat and poultry establishment once a year or when additional
New Updated CVS Establishment Profile
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poultry establishment once-a-year or when additional information is needed.
• All information will be captured in one secure central database (CVS database).
• Launch date: April 2012
Type of information that will be generated from the CVS database:
• How many plants in Canada are RTE and process dry cured products?
• How many plants grind beef?• How many plants use well water?
New Updated CVS Establishment Profile
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How many plants use well water?• How many plants use aseptic packaging?• How many federally registered meat and poultry
establishments also process fish or eggs or dairy?• How many plants process products under Risk Category 1,
2A and 2B?• Etc.
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Seasonal/Intermittent Operations
• In response to the number of establishments that operate on an infrequent basis, guidance was developed to provide a consistent and realistic approach to conducting CVS tasks at these operations.
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• The guidance consists of a questionnaire that is to be completed by the local staff and then communicated to the National Inspection Division (NID) for review.
• NID will determine the appropriate number and frequency of CVS tasks to be conducted for the period of operation.
Foreign Country Audit
• A new protocol is currently being developed to standardize the Agency's approach towards foreign audits.
• The protocol is to ensure foreign audits are
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The protocol is to ensure foreign audits are planned and implemented consistently. The protocol will provide guidance regarding:
• Audit logistics planning communication• Pre audit inspection activities • Post audit activities• Communicating / coordinating follow up activities in a
timely manner
Health Canada – Validation Guidelines
• Health Canada's "Policy on Listeria monocytogenes in Ready-to-Eat Foods - 2010" defines two risk categories for ready to eat meat and poultry products. In order to be classified into a risk category that permits a lower sampling and testing frequency, operators must provide validation data th t th t th i b t i i t ll d th h t
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that proves that pathogenic bacteria is controlled throughout the product shelf life.
• Operators of federally registered establishments are encouraged to wait for the Health Canada validation guidelines and related tools to be published to ensure their validation studies are completed correctly and contain all necessary information.
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Health Canada – Validation Guidelines
Interim procedures for Meat Program submissions
• Although the HC Guidelines have not yet been released, some operators may wish to submit documentation packages to the Meat Programs Division (MPD) for review and
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to the Meat Programs Division (MPD) for review and approval.
• These submissions are to be forwarded through your responsible inspector.
• All submissions will be reviewed by MPD with the CFIA Food Safety Division.
5 Most Common Tasks Rated U
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5 Most Common Tasks Rated U
Task # Title
1. 4.1.04 HACCP System Design
2. 1.2.14 Storage
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3. 1.2.04 & 1.2.41
Ventilation (non RTE & RTE)
4. 1.1.08 & 1.1.10
CCP Generic & CCP Cooling
5. 1.2.45 General Food Hygiene
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Exercise Instructions
Each table is assigned a number
Each table number is associated with one task
Table # Task # Title
1. 4.1.04 HACCP System Design
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2. 1.2.14 Storage
3. 1.2.04 & 1.2.41 Ventilation (non RTE & RTE)
4. 1.1.08 & 1.1.10 CCP Generic & CCP Cooling
5. 1.2.45 General Food Hygiene
Exercise Instructions
• A copy of each task is in your binder – tab 6
• Read the task
• Answer these questions• What are the most common deficiencies associated with the task?
• What are the most common causes?
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• What are the most common causes?
• How do you correct these deficiencies
• Short term
• Long term
• Identify a spokesperson
Questions & Answers
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